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PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

2014-07-24 14:11:23 | BioPortfolio

Summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care.

Description

Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue from both female breasts for therapeutic or cosmetic indications. The purpose of the breast reduction is to decrease the weight of the breasts and restructure the breast tissue for a more favorable appearance. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any excess tissue.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ENT surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing bilateral breast reduction.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Macromastia

Intervention

PEAK PlasmaBlade, Traditional Electrosurgery with scalpel

Location

Tri-City Medical Center
Oceanside
California
United States
92056

Status

Enrolling by invitation

Source

Peak Surgical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:23-0400

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A plant genus of the family AMARANTHACEAE, order Caryophyllales, which has been used in traditional medicine (MEDICINE, CHINESE TRADITIONAL).

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